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Despite serious opioid crisis, research on medical marijuana remains stifled by federal rules

Dr. Matt Layton, left, a psychiatrist with an interest in research, and John Roll, vice dean for research at the Elson Floyd Medical School at Washington State University, talk Thursday, July 13, 2017, about the many roadblocks to researching the uses and dangers of marijuana in the university setting. The complex layers of state and federal law prevents them for studying marijuana  as, for instance, a pain reliever. (Jesse Tinsley / The Spokesman-Review)
Dr. Matt Layton, left, a psychiatrist with an interest in research, and John Roll, vice dean for research at the Elson Floyd Medical School at Washington State University, talk Thursday, July 13, 2017, about the many roadblocks to researching the uses and dangers of marijuana in the university setting. The complex layers of state and federal law prevents them for studying marijuana as, for instance, a pain reliever. (Jesse Tinsley / The Spokesman-Review)

It’s about a mile along Division Street from Dr. Matt Layton’s office on the Washington State University medical campus in Spokane to the nearest recreational marijuana store.

As a private adult under Washington law, Layton could walk into that store, buy a gram of marijuana and use it however he sees fit at home (though he’s quick to point out he could lose his federal license to prescribe other drugs and probably his job if he were caught).

As a researcher, he can survey the chronic-pain patients and people addicted to opioids he works with and ask them if and how they’re using marijuana to manage their symptoms.

Here’s what he can’t do. As much as he’d like to, he can’t buy those same marijuana strains and work with colleagues in the WSU College of Pharmacy to analyze them and break down the cannabis compounds they contain. He can’t test those compounds in animals to see which combinations are most effective for treating pain.

And he especially can’t bring people into his lab, give some of them a local marijuana strain, some oxycodone and some a placebo and see how each group’s pain changes as a result.

Welcome to the confusing and often contradictory world of medical marijuana research.

‘No accepted medical use’

In a nation where the Centers for Disease Control and Prevention counted 15,000 Americans who died from prescription opioid overdoses in 2015, Layton is one of many researchers interested in alternatives to pain management that don’t rely on drugs that routinely cause fatal overdoses.

There’s some data showing there are fewer opioid overdoses in states that have legalized medical marijuana, though that data doesn’t prove causation between the two.

Yet rigorous medical research on marijuana, which many scientists see as a promising alternative for some patients, has been hamstrung thanks to federal regulations on its use by scientists.

“I’m not a proponent of using cannabis. I’m a proponent of science. So if it is a fact that it could help people better than opioids, why shouldn’t we know that?” said Marian Wilson, an assistant professor at the Washington State University College of Nursing who researches chronic pain and addiction.

Though marijuana is legal in 29 states for medical use, and in eight for recreational use, the Drug Enforcement Administration still classifies marijuana as a Schedule I drug alongside heroin, ecstasy and LSD. The DEA says Schedule I drugs have “no currently accepted medical use and a high potential for abuse.”

Most opioid painkillers fall into the next classification, Schedule II, alongside methamphetamine and cocaine: substances with a high potential for abuse that have recognized medical uses.

The DEA can’t change the definitions for each schedule level without an act of Congress, but it can reclassify drugs if it decides they no longer meet the criteria.

Former Washington Gov. Christine Gregoire petitioned the DEA in 2011 with then-Rhode Island Gov. Lincoln Chafee to reclassify marijuana as Schedule II based on its existing use for medical reasons. The DEA responded last August, denying that petition and a second, similar effort by a New Mexico medical marijuana advocate.

The denial was based on a recommendation from the Department of Health and Human Services, which “concluded that marijuana has a high potential for abuse, has no accepted medical use in the United States, and lacks an acceptable level of safety for use even under medical supervision.”

“Nothing has changed. We’re still facing the same set of regulations that we’ve had since 1973,” Layton said.

John Roll, the vice dean for research at WSU’s Elson S. Floyd College of Medicine, is on board with researchers who want to look at marijuana, but he said the university has to be cautious. Violating federal regulations in any way would be disastrous and could cost WSU federal funding for other types of research, in addition to stripping doctors like Layton of their prescribing licenses.

“We will never do anything with marijuana that’s not in compliance with federal and state regulations. That slows us down,” Roll said.

An alternative

to opioids

For proponents of medical marijuana, the idea that the drug can help with pain is a no-brainer. A 2017 review of available research on the health effects of marijuana by the National Academies of Sciences, Engineering and Medicine concluded there was “substantial evidence that cannabis is an effective treatment for chronic pain in adults” but noted there was next to no information about dosage or how best to administer the drug.

Those are questions doctors like Layton want answered. What sorts of side effects does marijuana have? What compounds in the drug work best for different types of pain? What dosage should be given?

“Right now I just have to say, ‘We don’t know,’ ” Layton said.

The result in states with legal marijuana is a sort of dual medical system. Doctors typically don’t recommend marijuana to chronic pain patients, and many actively encourage patients not to use it. At some practices, patients receiving opioid prescriptions may be drug-tested or required to sign a contract saying they won’t use illicit substances, including marijuana.

That works about as well as prohibition typically does. Wilson recently completed a study of both chronic pain patients and people in treatment for opioid addiction. While she’s still analyzing the data, she said about half of the people in addiction treatment reported using marijuana in the past month, and many said they believed the drug helped them take fewer opioids.

Layton sees the same behavior among the patients he works with. He serves as medical director of the Spokane Regional Health District’s opioid treatment program, and said many of his patients there have chronic pain they’re trying to medicate.

“They’re going out and they’re finding what they can and they’re using it in a totally unregulated way as opposed to us having evidence and real data,” he said.

That concerns medical professionals in part because they encounter many people who believe marijuana in every form is a completely benign drug.

Years of hyperbolic anti-drug messaging that severely overstated the dangers of marijuana may have made some people reluctant to consider that, like any plant or drug, it can have side effects and works differently in different people.

The National Academies of Sciences, Engineering and Medicine review also concluded there’s substantial association between using cannabis and the development of schizophrenia or other disorders involving psychosis, and moderate evidence that marijuana use is associated with worsening symptoms of some mental illnesses, including mania in people with bipolar disorder.

The feds’

marijuana farm

Under current regulations, it’s not impossible to research marijuana’s effects in humans. It’s just very difficult.

The easiest way is through observational studies, where researchers interview people about their use of the drug and other topics they’re interested in.

Some WSU researchers are working on projects like this, looking at questions like how the children of mothers who smoke marijuana during pregnancy fare or how effective Department of Health campaigns to discourage children from using the drug are.

Layton is trying to get a study started to do human drug trials of marijuana for chronic pain treatment.

He has support from the university and plans to begin the process of seeking federal approval soon. His hope would be to work with the College of Pharmacy to analyze the components in marijuana and understand why it works the way it does in the body.

“We want to understand how the body deals with cannabis better. What does it metabolize it into? How long does it stay in the body? How do you appropriately dose it?” he said.

Two things make research of the sort Layton wants to do difficult.

The first is working with marijuana in a lab setting. Because it remains illegal under federal law, researchers can’t just go down the street and buy a few grams of a strain they’re interested in.

Instead, they have to get a license to handle Schedule I drugs from the DEA. The university has to have a secure storage facility with special locks, cameras and a log showing who’s checking out how much of the drug.

Then, scientists have to order the marijuana from the National Institute on Drug Abuse, a research institution within the National Institutes of Health. NIDA is the only legal way to get marijuana for research, and its supply is grown exclusively on the University of Mississippi campus.

Testing marijuana for THC levels, which are an indicator of potency, is an inexact science, but the products NIDA has available range from 1 percent to just over 10 percent THC, according to the institute.

Marijuana advertised for sale in Washington retail stores typically ranges from 10-30 percent THC, and researchers say the federal stuff is a poor analog to what their patients are using in the real world.

“We can’t compare apples to apples. We don’t really know how the products people are using for real, how that compares to the science that’s being done on a very low THC content,” Wilson said.

In what some researchers say is an encouraging sign, the DEA did announce last August that it would open applications to additional marijuana suppliers, a move that they hoped would supply scientists with a more “varied and robust supply of marijuana.”

Pain research

Layton wouldn’t be the first WSU scientist working with marijuana in the lab. Rebecca Craft, a psychology professor on the Pullman campus, works with marijuana and other drugs in rats and is especially interested in how the effects of drugs change based on gender.

She’s had a Schedule I license for 15 years and tests marijuana compounds in rats. Right now, she’s focusing on cannabidiol, better known as CBD, and its effects on rodent pain. CBD, along with THC, is one of the more studied compounds in marijuana and is believed to be responsible for some of the drug’s apparent therapeutic effects, while THC controls more of the psychoactive properties.

Craft said she’s been approached by marijuana growers and processors asking her to test their products or try to empirically verify what they’re hearing from customers about how different strains help with ailments.

“We’ve had to say no to all of those folks. We cannot legally partner with them,” Craft said.

To look at the drug in humans, scientists also have to get approval from the Food and Drug Administration, which regulates new drug trials.

Research like that is underway in Colorado, thanks to a $9 million grant program through the Colorado Department of Health.

The money came after the state realized it was charging more for medical marijuana permits than was needed to sustain the program and the Legislature decided to set the money aside for medical research, said Ken Gershman, who leads the grants program for the state.

Nine studies, including three clinical trials, are underway. The trials include investigating marijuana’s effects on veterans with post-traumatic stress disorder and looking at its effectiveness treating spinal pain.

Emily Lindley, an assistant orthopedics professor at the University of Colorado’s Anschutz Medical Campus, said the pain study started because patients kept reporting to spine surgeons that using marijuana was helping them cope with neck and back pain.

Existing research on marijuana and pain has largely focused on neuropathic pain, she said, caused by tissue injury where nerves may be damaged or injured.

“There hasn’t really been anything on other forms of pain that are really common,” she said.

She received funding for a drug trial in December 2014, but is only now starting to recruit subjects because of the length of time needed to get federal approval.

Patients in her study will come into the lab on three different days and be given a drug each time: active marijuana, a placebo designed to look and smell like marijuana, and oxycodone. Patients will then report on their pain and side effects and be tested for pain tolerance.

The trial is double-blind, meaning neither the subject nor the researcher will know which substance the patient is receiving on a given day. Half the subjects will be healthy people without chronic pain and half will have chronic pain issues.

Layton hopes he could join the ranks of researchers doing similar studies in the next few years.

“We want to do real science,” he said.


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